Devipasta

Package Leaflet: Information for the User

DEVIPASTA, (450 mg + 370 mg)/g, paste

(Paraformaldehyde + Lidocaine)

Table of Contents of the Leaflet:

• 1. What is Devipasta and what is it used for
• 2. Important information before using Devipasta
• 3. How to use Devipasta
• 4. Possible side effects
• 5. How to store Devipasta
• 6. Package contents and other information

1. What is Devipasta and what is it used for

Devipasta is an arsenic-free paste used in endodontics for the devitalization of dental pulp in mortal methods of treating irreversible pulpitis.
Pharmacotherapeutic group: digestive tract and metabolism; dental preparations; other agents for local oral use; ATC code: A01AD11

Pharmacodynamic properties

Paraformaldehyde, being a product of the polymerization of formaldehyde, undergoes slow depolymerization in the tooth chamber, as a result of which formaldehyde molecules gradually penetrate the pulp, causing its complete necrosis after 6-8 days. Living tissue under the influence of formaldehyde first becomes irritated, and then necrotic and mummified; the action develops slowly and gently as the paraformaldehyde depolymerizes gradually in the tooth chamber, which reduces the likelihood of irritation of the periodontal tissue.
Thus, in addition to its devitalizing effect, paraformaldehyde mummifies the pulp and creates a demarcation line at the border of the periodontal tissue. The use of paraformaldehyde therefore shortens the treatment by one visit, which is intended to apply a mummifying agent. A disadvantage of paraformaldehyde is the occurrence of pain attacks during its use; thanks to the content of a strong anesthetic, i.e., lidocaine, which also interacts with paraformaldehyde in the devitalization of the pulp, the drug does not cause pain after application.
Lidocaine is a local anesthetic (mucosal anesthetic) from the group of amide derivatives with a short duration of action. It causes reversible inhibition of conduction in nerve fibers by blocking the sodium-potassium pump and inhibiting the permeability of the cell membrane to ions.
The other ingredients of the drug are auxiliary substances and give the paste the required consistency.

Pharmacokinetic properties

After applying Devipasta to the open tooth chamber and covering the tooth chamber with dental cement, formaldehyde is slowly released from the paraformaldehyde and acts denaturingly on the blood vessels and destroys the nerve endings of the tooth. The formed demarcation line of denatured dentin prevents the absorption of paraformaldehyde into the body and prevents the absorption of lidocaine, which acts only locally. Lidocaine in its base form is not soluble in water, and after the formation of the demarcation line by paraformaldehyde, it also does not undergo absorption into the body.
After applying Devipasta to the tooth chamber, the paraformaldehyde contained in the drug acts denaturingly on the dental pulp and dentocytes and does not undergo distribution to other body tissues. Also, lidocaine used in combination with paraformaldehyde does not undergo absorption from the tooth chamber into the tissues.

2. Important information before using Devipasta

When not to use Devipasta:

• in children under 4 years of age;

Warnings and precautions

Particular attention should be paid to the expiration date of the drug. Do not use the expired drug.

Overdose

No cases of overdose have been reported.

Pregnancy and breastfeeding

There is insufficient evidence regarding the safety of using Devipasta in pregnant women, therefore the drug should not be used in pregnant women.
The safety of use in breastfeeding women has not been determined.

Driving and operating machinery

Devipasta does not affect the ability to drive vehicles and operate machinery.

3. How to use Devipasta

Perform a trepanation of the tooth chamber roof.
If the bottom of the cavity is separated by a thick layer of dentin, anesthesia can be performed, and the drilling of tissues will be painless. In the case where this layer is thin or changed by caries, the exposure can be done without anesthesia, the pain is then short-lived. In each case, the entrance to the chamber should be large enough for the exudate to escape, which will ensure that no pain occurs after application.
Apply about 2 to 4 mg of paste (i.e., a ball with a diameter of 1.5 to 2 mm, depending on the size of the tooth) to the exposed pulp (at the trepanation point) using a spatula, gently, without pressure. Although there is no need to fear overdose, the paste should be applied to the exposure in an amount of 2 to 4 mg.
Immediately after the paste, place a cotton ball, making sure not to push the devitalizing agent into the tooth cavity, and then a tight temporary dressing, e.g., with glass-ionomer cement. The filling should be applied tightly to prevent the devitalizing agent from flowing towards the marginal periodontal tissue.
The dressing should remain in the tooth for 10 to 14 days. After 6-8 days, the product causes necrosis of the pulp, and after a further 2-6 days, mummification of the pulp occurs.
The medicinal product can be applied again if the pulp has not been devitalized, but never in the root canal.
The medicinal product should be used only in the absence of the possibility of treating pulpitis by amputation and extirpation.

4. Possible side effects

Like any drug, Devipasta can cause side effects, although they do not occur in everyone.
A transient pain may occur after applying the paste.
Rarely, hypersensitivity to paraformaldehyde.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of the drug.

5. How to store Devipasta

Store in a refrigerator (2°C - 8°C). Do not freeze.
Store the container tightly closed.
The drug should be stored out of sight and reach of children.
Pay attention to the expiration date of the drug.
Do not use Devipasta after the expiration date stated on the packaging. The expiration date means the last day of the given month.

6. Package contents and other information

What Devipasta contains

• The active substances of the drug are paraformaldehyde and lidocaine. 1 g of paste contains 450 mg of paraformaldehyde and 370 mg of lidocaine.
• The other ingredients are: purified cellulose wool, glycerol.

What Devipasta looks like and what the package contains

Devipasta is a white, homogeneous, hard mass with a characteristic paraformaldehyde odor.
The immediate packaging is a PP container with a PP cap with a polypropylene seal, containing 5 g of paste, placed together with the leaflet in a cardboard box.

Marketing authorization holder and manufacturer

CHEMA-ELEKTROMET
Cooperative
ul. Przemysłowa 9
35-105 Rzeszów
tel. 17 862 05 90
e-mail: chema@chema.rzeszow.pl

Date of the last update of the leaflet: